Protection of human subjects in intervention research for suicidal behavior.

OBJECTIVE: Three domains of ethical conduct outlined in the U.S. Food and Drug Administration's 1998 Belmont Report on protection of human research subjects-respect for persons, beneficence, and justice-have posed specific dilemmas in the design of intervention studies for suicidal behavior. These issues include questions about suicidal patients' capacity to provide informed consent, the risk of some lethal outcomes, the possibility of imminent suicide risk associated with patients' right to discontinue the study treatment, and the need for a higher level of monitoring of suicidal patients. The authors examine these and other issues and discuss ways they can be addressed in research design.
METHOD: To illustrate solutions to these bioethical tensions, the authors describe the design of a randomized, controlled trial of pharmacotherapy for suicidal behavior in bipolar disorder.
RESULTS: Using surrogate outcome measures, allowing prescription of rescue medications, integrating psychosocial interventions, and providing close clinical monitoring enable researchers to conduct research on suicidal behavior while maximizing adherence to the ethical recommendations outlined in the Belmont Report. Alternative study designs, such as add-on trials, in which the study treatment or placebo is added on to known effective treatment, may also be used in research on suicidal behavior.
CONCLUSIONS: It is possible to design a randomized, controlled trial that minimizes the risk of morbidity and mortality for suicidal patients with bipolar disorder, but deliberation is required to address the bioethical tensions that arise.

RCT Entities:   Population Interventions Outcomes